To Produce Low-cost, Generic Version of Pfizer’s Oral COVID-19 Treatment nirmatrelvir In Combination With ritonavir For Supply in 95 Low- and Middle-income Countries
SHANGHAI CHINA, March 18, 2022—Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma” or “Group”; Stock Code: 600196.SH, 02196.HK) announced that Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. (“‘Fosun Pharmaceutical Industrial”), a subsidiary company of Fosun Pharma, has signed a sublicense agreement with the Medicines Patent Pool (MPP), to manufacture the generic version of Pfizer’s oral COVID-19 treatment nirmatrelvir, which co-packaged with a low dose of ritonavir, can be supplied in 95 low- and middle-income countries (LMICs) comprising approximately 53% of the world’s population.
According to the sublicense agreement, MPP offered a non-exclusive sublicense to Fosun Pharmaceutical Industrial to produce the active pharmaceutical ingredient nirmatrelvir and a generic version of the finished drug itself, nirmatrelvir co-packaged with ritonavir. The manufacturing facilities for the related product under this sublicense are subject to approval by a strict regulatory authority (SRA) or pre-qualified by the World Health Organization (WHO).
“We are glad to reach an agreement with MPP to jointly commit to increasing the global access of COVID-19 antiviral medicines.” said Wu Yifang, Chairman and CEO of Fosun Pharma. “As a company with strong social responsibility, Fosun Pharma always takes innovation as a core driving force in our development. With our global footprints, we are committed to addressing unmet clinical needs and improving the accessibility and affordability of COVID-19 treatments in low- and-middle-income countries worldwide. We will continue to contribute to the global pandemic response on COVID-19 and to help save more lives.”
The nirmatrelvir tablets and ritonavir tablets combination is a co-packaged oral COVID-19 treatment for adults with mild to moderate COVID-19 with high-risk factors for progression to severe diseases. Nirmatrelvir (tablets) (PF-07321332) is a SARS-CoV-2 main protease（Mpro，also known as 3CL protease) inhibitor, and ritonavir, an HIV-1 protease inhibitor and CYP3A inhibitor. Co-administration nirmatrelvir with a low dose of ritonavir helps slow the metabolism, or breakdown of nirmatrelvir in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.
In December 2021, the co-packaged product of nirmatrelvir and ritonavir (under the brand PAXLOVIDTM) from Pfizer was authorized emergency use authorization by the US Food and Drug Administration. It was also authorized conditional approval by the European Medicines Agency in January 2022, fast-track approval by the Japanese Ministry of Health, Labour and Welfare in February 2022, and emergency conditional approval by the National Medical Products Administration of China in February 2022. The drug has now approved for emergency use or conditional authorization in more than 50 countries.
As an innovation-driven international healthcare group in China, Fosun Pharma implements its internationalization strategy in terms of innovative R&D, BD, production, operation, and commercialization. At the same time, Fosun Pharma accelerates the international quality system certification of its manufacturing sites, and enhances its international commercialization capabilities to further expand the international market. After 15 years’ operation in Africa, Fosun Pharma has built a comprehensive distribution network in 35 English and French-speaking Africa countries.
In January 2022, Fosun Pharma signed sublicense agreement with MPP to produce low-cost versions of COVID-19 antiviral medication molnupiravir (MK-4482 and EIDD-2801) for supply in 105 low- and-middle-income countries to help make the anticipated treatments rapidly available in LMICs so as to help end this pandemic for the world.
About Fosun Pharma
Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; stock code: 600196.SH, 02196.HK) is a leading innovation-driven international healthcare group in China. Fosun Pharma strategically operates businesses in the pharmaceutical and health industry, including pharmaceutical manufacturing, medical devices and medical diagnosis, and healthcare services. Through equity participation in Sinopharm Co., Ltd., Fosun Pharma’s business extends to pharmaceutical distribution and retail.
Fosun Pharma takes pharmaceutical manufacturing as its core business and sticks to innovative research and development. Through in-house R&D, co-development, in-licensing and incubation, Fosun Pharma has established platforms for small molecule innovative drugs, antibody drugs and cell therapy, focusing on major therapeutic areas, including oncology, immunology, the “4 hypers” (hypertension, hyperlipidemia, hyperglycemia and hyperuricemia) and their complications, as well as central nervous system. In the meantime, Fosun Pharma keeps close track of cutting-edge technologies, such as targeted protein degradation, RNA, oncolytic virus and gene therapy to enhance its innovation ability.
Looking forward, under guidance of 4IN strategy (Innovation, Internationalization, Integration and Intelligentization), Fosun Pharma practices innovation and transformation, integrated operation and steady development, as well as the concept of sustainable development. Fosun Pharma is committed to becoming a first-class enterprise in the global mainstream healthcare industry.
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